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ABOUT THIS PAGE
A Ramosetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ramosetron, including repackagers and relabelers. The FDA regulates Ramosetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ramosetron API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ramosetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ramosetron supplier is an individual or a company that provides Ramosetron active pharmaceutical ingredient (API) or Ramosetron finished formulations upon request. The Ramosetron suppliers may include Ramosetron API manufacturers, exporters, distributors and traders.
click here to find a list of Ramosetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ramosetron Drug Master File in Japan (Ramosetron JDMF) empowers Ramosetron API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ramosetron JDMF during the approval evaluation for pharmaceutical products. At the time of Ramosetron JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ramosetron suppliers with JDMF on PharmaCompass.
Ramosetron Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ramosetron GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ramosetron GMP manufacturer or Ramosetron GMP API supplier for your needs.
A Ramosetron CoA (Certificate of Analysis) is a formal document that attests to Ramosetron's compliance with Ramosetron specifications and serves as a tool for batch-level quality control.
Ramosetron CoA mostly includes findings from lab analyses of a specific batch. For each Ramosetron CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ramosetron may be tested according to a variety of international standards, such as European Pharmacopoeia (Ramosetron EP), Ramosetron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ramosetron USP).
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